Phase 4
N=20
Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00754546 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Exercise Endurance Time — 490; 333; 472; 362 seconds — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Arformoterol tartrate (Drug); Placebo: Normal Saline (Drug); Treadmill Exercise (Other); Cycle Exercise (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Endurance Time |
490; 333; 472; 362 | < 0.05 sig |
| SECONDARY Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise |
1.27; 1.79; 1.42; 1.49 | — |
Summary
Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.
Eligibility Criteria
Inclusion Criteria
- male or female patient 50 years of age or older; diagnosis of COPD; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of < 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator FEV1 < 80% predicted; a post-bronchodilator FEV1/FVC ratio < 70%; and clinically stable condition.
Exclusion Criteria
- any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing
Data sourced from ClinicalTrials.gov (NCT00754546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.